On January 1, 2025, the Republic of Indonesia will officially implement Electronic Catalogue Version 6 for the procurement of goods and services, in accordance with a directive from the President of the Republic of Indonesia. As part of this transition, Electronic Catalogue Version 5 will be deactivated on December 31, 2024, except for specific categories […]
The Health Sciences Authority (HSA) of Singapore has issued a new guidance document, “GN-37-R1 Change Management Program (CMP) for SaMD, including machine-learning enabled SaMD,” which became effective on 4th December 2024. Key Highlights of GN-37-R1 Introduction of the Change Management Program (CMP) The CMP provides a framework for “pre-specified changes” that SaMD manufacturers can implement
On December 4, 2024, the Thai FDA announced revisions to the regulations governing medical device advertising. These updates, outlined in the “Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License Validity for Medical Device Advertising B.E. 2568 (2025)”, aim to enhance clarity and ensure alignment
The Ministry of Health (MoH) of Indonesia has announced an update regarding the listing of medical device products in the e-Catalogue managed by the National Public Procurement Agency (LKPP: Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah). This update affects stakeholders who sell their medical device products through the government purchasing system. Extended Deadline for Product Listing The
Indonesia: Update on Listing Product Schedule in the Ministry of Health e-Catalogue Read More »
As Cambodia’s regulatory landscape evolves, our Cambodia team provides strategic insights and proactive guidance for market entry and compliance. Fluent in Khmer, with a deep understanding of the local market, they help ensure your business thrives in this emerging region.
Our Singapore team is at the forefront of product registration, post-market surveillance, and navigating customs regulations. With proficiency in English and Mandarin, and expertise in ISO 13485 standards, they provide comprehensive support to help clients succeed in a fast-changing regulatory landscape.
Our Philippines team specialises in navigating local regulatory frameworks, providing expertise in product licensing, adverse event reporting, and post-market surveillance. Fluent in Filipino and English, their local presence and industry expertise ensure compliance at every stage.
Our Vietnam team brings extensive expertise in the medical device sector, offering key insights into regulatory changes, product registration, and compliance monitoring. Fluent in Vietnamese, they ensure your business stays competitive and fully compliant in this fast-evolving market.
Our Malaysia team consists of regulatory and distribution experts, offering compliance solutions in both Bahasa Malaysia and English. With a proven history of successful product registrations and market launches, they bring deep insights into the local healthcare ecosystem. From consultation to approval, they provide comprehensive support through every stage of the regulatory process.
Specialising in product registration, post-market surveillance, and local compliance in Bahasa Indonesia, our local team is able to offer seamless market access minus the fuss. Our team has years of experience and deep understanding of Indonesia’s unique regulatory environment, which helps expedite the approval process and ensure that all regulatory requirements are met accurately and efficiently.
Melody oversees logistics, ensuring efficient execution of services from market entry to compliance. With a strong grasp of local customs and regulations, she ensures timely deliveries and strict regulatory adherence.
Leading our business development and client relationship efforts, ShouZheng brings extensive experience in medical device market trends across Southeast Asia. Their insights enable teams to stay focused on client needs and regional market demands.
As CEO, Mourad steers the company’s strategic direction, fostering a unified approach across all regions. With [XX] years of industry experience, Mourad provides strong leadership, ensuring each team is equipped to meet client needs effectively.
May spearheads our global marketing strategy, ensuring each region’s distinct value proposition is communicated clearly. Her expertise ensures a cohesive brand presence while customising messages to resonate with local markets.
Paul oversees operational efficiency across all regions, ensuring teams perform at their highest potential. With expertise in operational management, he ensures seamless execution of every project, from product registration to market launch.
As CEO, Mourad steers the company’s strategic direction, fostering a unified approach across all regions. With years of industry experience, Mourad provides strong leadership, ensuring each team is equipped to meet client needs effectively
On December 20, 2024, the Vietnam Ministry of Health (MoH) issued a draft amendment and supplement to several articles of Decree No. 98/2021/ND-CP, dated November 8, 2021, on Medical Devices Management. This draft follows previous amendments introduced by Decree No. 07/2023/ND-CP, dated March 3, 2023. The draft aims to enhance regulatory processes while addressing key
On December 16, 2024, the Indonesian Ministry of Health issued Notification Letter No. FR.03.01/E.V/2672/2024, classifying Dried Blood Spot as a medical device. This update provides significant regulatory implications for manufacturers, importers, and distributors of the product. Below is a detailed summary of the notification and its key requirements: Details of the Product and Its Classification
Indonesia: Notification of Dried Blood Spot Product Classification as a Medical Device Read More »
The Ministry of Health in Indonesia has announced a temporary closure of its medical devices licensing system and online certification platform for maintenance purposes, as outlined in Announcement No. FR.03.01/E.V/2653/2024, dated December 11, 2024. System Closure Details Medical Device Licensing System The medical device online registration system (REGALKES) available at https://regalkes.kemkes.go.id will be temporarily closed
The Food and Drug Administration (FDA) has announced the implementation of a new schedule of fees and charges under Administrative Order No. 2024-0016. For over two decades, the FDA’s fees were governed by Administrative Order No. 50 s. 2001. The restructuring of fees aims to align charges with the costs of regulating health products, establishments,
On November 27, 2024, the Philippine Food and Drug Administration (FDA) released Administrative Order No. 2024-0015, introducing updated regulations on the License to Operate (LTO) requirements for health product establishments. This includes rules for initial applications, renewals, and variations, applicable to medical device distributors (importers, exporters, wholesalers), manufacturers (including packers, repackers, refurbishers, and traders), and
The Philippine Food and Drug Administration (FDA) has concluded the pilot implementation of the Certificate of Medical Device Notification (CMDN) application process through the eServices Portal System. This initiative, outlined in FDA Advisory No. 2024-1089, applied exclusively to applicants within the National Capital Region (NCR). The FDA has issued the following updates for stakeholders and
The Thai Food and Drug Administration (FDA) has officially announced the rates for expenses related to monitoring, auditing, and surveillance activities aimed at ensuring compliance with medical device regulations. This new fee structure, effective from November 13 2024, addresses expenses for document evaluation, testing, facility inspections, and related activities to control the manufacturing, importation, and
On November 19, 2024, the Infrastructure and Medical Device Administration (IMDA) issued Letter No. 519/HHTB-DKKD, requesting enterprises to provide details about class C and class D medical devices with import licenses that were set to expire on December 31, 2024. The IMDA sought this information to synthesize, report, and propose solutions to the Ministry of
Malaysia’s Medical Device Authority (MDA) has issued a draft guidance document for the first edition of Control of Obsolete and Discontinued Medical Devices in Healthcare or Related Facilities. This article provides guidelines on managing medical devices that are obsolete or discontinued to ensure uninterrupted healthcare operations. Obsolete Devices The manufacturer must officially declare a device
Malaysia: Managing Obsolete and Discontinued Medical Devices in Healthcare Facilities Read More »
The Ministry of Health (MOH) in Vietnam issued Circular 29/2024/TT-BYT on November 3, 2024, mandating the price declaration of certain medical devices based on their technical and economic characteristics. This circular specifies the requirements for declaring prices, including the product name and specific model, and will take effect on January 1, 2025: Specific model Detailed
Vietnam: New Circular on Mandatory Price Declaration for Selected Medical Devices Read More »
On October 30, 2024, the Deputy for Digital Procurement Transformation at Indonesia’s National Public Procurement Agency (LKPP) issued a decision to deactivate the Electronic Catalogue Version 5, aimed at streamlining the e-Catalogue business process. Key Conditions for Deactivation: Key Conditions for Deactivation: Deactivation of Product Showcase Creation for Local/Sectoral e-Catalogue: Effective immediately, the feature to
Indonesia: Deactivation of the Electronic Catalogue System Version 5 Read More »
The Thai Food and Drug Administration (FDA) has issued a draft announcement detailing the criteria, methods, and conditions for requesting, issuing, and managing licenses for medical device advertising. This new draft aims to regulate and control medical device advertisements to ensure accurate, ethical, and culturally appropriate messaging. Key Highlights of the Draft Announcement: Revocation of
Thailand: Draft Announcement on Medical Device Advertising Licenses by the Thai FDA Read More »
On October 10, 2024, Indonesia’s Ministry of Health (MoH) announced the opening of an International Tender Procurement for a project named Strengthening Indonesia’s Healthcare Referral Network (SIHREN). The official announcement is available on the e-Catalogue website in both Indonesian and English. You can access it here. Further details about the procurement process are available in
Indonesia: Announcement on International Tender Procurement by Ministry of Health Read More »
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